Pantoprazole Sodium

Product NDC: 0378-6689
11-digit product format: 003786689
Labeler code: 0378
Product ID: 0378-6689_38896560-f523-4d0b-8113-5ff7f5f38c81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pantoprazole sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA090970
Marketing category: ANDA
Marketing start: 2011-01-19
Substance: PANTOPRAZOLE SODIUM
Active strength: 40 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0378-6689	0378-6689-99	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090970-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2011-01-19
A090970-002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2011-01-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090970-001	AB
A090970-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090970-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090970-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090970-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090970-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090970-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090970-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090970-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090970-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090970-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090970-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090970-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090970-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090970-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090970-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090970-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090970-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090970-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090970-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090970-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090970-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090970-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090970-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090970-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090970-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090970-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090970-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090970-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090970-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090970-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090970-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090970-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090970-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090970-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090970-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090970-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090970-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090970-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090970-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090970-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090970-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090970-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090970-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pantoprazole Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PANTOPRAZOLE SODIUM	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6871619Q5X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
251872	Internal RxNorm lookup
314200	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
56ad5b97-8e5f-48a5-b2ba-a5484b43d018	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ae9ebba7-ac9e-4a6e-90ef-4bd9760ec041	Product name	8	20260304
41d62193-73fc-49cf-9907-add9588e2da1	Product name	9	20260112
f12d0d0d-c068-46c6-872c-96c9d38533bb	Product name	1	20250116
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0378-6689-10	Pantoprazole Sodium	1000 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	1000	18
0378-6689-77	Pantoprazole Sodium	90 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	90	18
0378-6689-99	Pantoprazole Sodium	90 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	90	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-6689-10	EA - Each	0378-6689	741cb237-7b4a-4c19-be55-2f7f6957c6ee	1	2012-07-24
0378-6689-77	EA - Each	0378-6689	7f77490b-a8d3-48e8-a8e2-bc264dcfcba8	1	2012-07-24
0378-6689-99	EA - Each	0378-6689	b7d979b2-7c64-4d66-b67c-66cb558623e1	1	2020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	4
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM DELAYED RELEASE TABLET, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS]	1
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM DELAYED RELEASE TABLET, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-6689	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	18	Current NDC, Legacy NDC, 3 package rows	20230923_56ad5b97-8e5f-48a5-b2ba-a5484b43d018.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	e17e4a72-d6a4-4a83-a921-88af9ef028a6	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090970 application number: ANDA090970
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Safecor Health LLC	5e1cbf26-d379-4315-8732-3939968f32c0	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090970 application number: ANDA090970
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	QPharma Inc	fbd035d0-529c-6033-e053-6294a90abf07	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090970 application number: ANDA090970
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Mylan Institutional Inc.	a9b0d279-118b-4372-bd51-d4bad9c1cfca	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090970 application number: ANDA090970
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	d27e1fdd-e23f-0d60-e053-2a95a90a9087	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090970 application number: ANDA090970
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	6faf465b-c3a3-4ae7-9e16-1ba758f6962a	2024-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090970 application number: ANDA090970
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Bryant Ranch Prepack	7d51104d-b135-421f-8425-03b5772e7103	2024-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090970 application number: ANDA090970
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Mylan Pharmaceuticals Inc.	56ad5b97-8e5f-48a5-b2ba-a5484b43d018	2023-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090970 application number: ANDA090970 ndc (product): 0378-6689

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6871619Q5X	PANTOPRAZOLE SODIUM	164579-32-2	PANTOPRAZOLE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	6faf465b-c3a3-4ae7-9e16-1ba758f6962a	21
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	6faf465b-c3a3-4ae7-9e16-1ba758f6962a	21
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	6faf465b-c3a3-4ae7-9e16-1ba758f6962a	21
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	a9b0d279-118b-4372-bd51-d4bad9c1cfca	19
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	a9b0d279-118b-4372-bd51-d4bad9c1cfca	19
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	a9b0d279-118b-4372-bd51-d4bad9c1cfca	19
251872	pantoprazole sodium 20 MG Delayed Release Oral Tablet	PSN	56ad5b97-8e5f-48a5-b2ba-a5484b43d018	18
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	56ad5b97-8e5f-48a5-b2ba-a5484b43d018	18
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	56ad5b97-8e5f-48a5-b2ba-a5484b43d018	18
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	56ad5b97-8e5f-48a5-b2ba-a5484b43d018	18
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	56ad5b97-8e5f-48a5-b2ba-a5484b43d018	18
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	56ad5b97-8e5f-48a5-b2ba-a5484b43d018	18
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	7d51104d-b135-421f-8425-03b5772e7103	6
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	7d51104d-b135-421f-8425-03b5772e7103	6
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	7d51104d-b135-421f-8425-03b5772e7103	6
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	fa2bee95-97db-e651-e053-6294a90a72f5	3
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	fbd035d0-529c-6033-e053-6294a90abf07	3
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	fa2bee95-97db-e651-e053-6294a90a72f5	3
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	fbd035d0-529c-6033-e053-6294a90abf07	3
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	fa2bee95-97db-e651-e053-6294a90a72f5	3
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	fbd035d0-529c-6033-e053-6294a90abf07	3
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	5e1cbf26-d379-4315-8732-3939968f32c0	2
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	5e1cbf26-d379-4315-8732-3939968f32c0	2
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	5e1cbf26-d379-4315-8732-3939968f32c0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-6689-10	00378668910	1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-10)	2011-01-19	0000-00-00	No	No	Current
0378-6689-77	00378668977	90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-77)	2011-01-19	0000-00-00	No	No	Current
0378-6689-99	00378668999	90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-99)	2020-02-19	2022-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pantoprazole Sodium	Safecor Health LLC	2026-04-07	HUMAN PRESCRIPTION DRUG LABEL	2
Pantoprazole Sodium	QPharma Inc \| Mylan Pharmaceuticals Inc. \| Northwind Health Company, LLC	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	3
Pantoprazole Sodium	Mylan Institutional Inc.	2025-07-22	HUMAN PRESCRIPTION DRUG LABEL	19
Pantoprazole Sodium	NCS HealthCare of KY, LLC dba Vangard Labs	2024-09-19	HUMAN PRESCRIPTION DRUG LABEL	21
Pantoprazole Sodium	Redpharm drug	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	3
Pantoprazole Sodium	Bryant Ranch Prepack	2024-05-20	HUMAN PRESCRIPTION DRUG LABEL	6
Pantoprazole Sodium	Mylan Pharmaceuticals Inc.	2023-08-15	HUMAN PRESCRIPTION DRUG LABEL	18
Pantoprazole Sodium	Lake Erie Medical DBA Quality Care Products LLC	2021-11-11	HUMAN PRESCRIPTION DRUG LABEL	7
Pantoprazole Sodium	REMEDYREPACK INC.	2019-08-27	HUMAN PRESCRIPTION DRUG LABEL	4
Pantoprazole Sodium Delayed Release - Northwind Pharmaceuticals	Northwind Pharmaceuticals	2014-06-06	HUMAN PRESCRIPTION DRUG LABEL	1